NTRK fusions are rare generally, but their prevalence can vary considerably between cancers, from 1 percent or less in some solid tumors among adults to more than 90 percent in infantile fibrosarcoma, which affects infants and young children. "This approval brings further hope to people with this rare type of the disease", said Janet Freeman-Daily, co-founder of The ROS1ders, a group of patients and caregivers affected by ROS1-positive lung cancer.

Duration of response ranged from 2.8 months to 26 months and objective responses to Rozlytrek were seen in people with central nervous system metastases at baseline.

The studies also included data for 53 patients with ROS1-activating gene fusions. Among the patients with locally advanced or metastatic ROS1-positive NSCLC, the ORR was 77.4% with a median DOR of 24.6 months, and the intracranial ORR was 55.0%.

Rozlytrek was approved by the U.S. Food and Drug Administration on Thursday to treat certain types of solid tumors, which show NTRK fusions.

STARTRK-NG, a phase I/IIb dose escalation and expansion study that evaluated the safety and efficacy of the drug in children and adolescent patients who had no curative first-line treatment options, recurrent or refractory extracranial solid tumors or primary CNS tumors, with or without TRK, ROS1, or ALK fusions.

Rozlytrek (entrectinib) is an oral medicine for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC), as well as for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The FDA continues to encourage the inclusion of adolescents in clinical trials. This approval is also based on data from the Phase I/II STARTRK-NG study in pediatric patients.

Previously, entrectinib had received priority review, breakthrough therapy, and orphan drug designations from the FDA.

This marks the third time the regulatory body has approved a cancer treatment based on a common biomarker across different types of tumours rather than the location in the body where the tumour originated. The accelerated approval of Rozlytrek for NTRK gene fusion-positive solid tumors is based on tumor response rate and durability of response, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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